Title: Sr. Director of Regulatory Affairs & Quality Assurance
Location: Northridge, Ca
Description: The Sr. Director of Regulatory Affairs and Quality Assurance is responsible for ensuring HemaCare maintains compliance with and following: Quality Systems, cGMP and cGTP models, Institutional Review Board determinations and all applicable Federal, State, Local, International, and Industry regulations and standards.
Responsible for monitoring compliance with all applicable regulations (Local, State, Federal, International, FDA, AABB, OSHA and other applicable agencies). Monitoring is achieved through performing internal audits, managing deviations, BPDR, MRB, review, and approval of standard operational procedures (SOP) and other Quality Systems reports.
Maintain and approve written procedures for production and process control designed to assure that products have the safety, quality, identity, purity, and strength that they purport to possess.
Develop, operate and maintain the effectiveness of the Quality Management System, the processes, and procedures; Document Control, Deviations, Change Control, CAPA, Internal Auditing & Quality Management Review.
Facilitate the development and maintenance of quality systems supporting pre-clinical, clinical, manufacturing, storage and distribution activities related to GMP products.
Maintain a Master Validation Plan and system that describes initial qualification (IQ, OQ, PQ) and revalidation.
Responsible for the design, implementation, and effectiveness of the GxP training system.
Responsible for all official communications with Federal and State regulatory agencies including timely response to external inspections and assessments.
Provide consultation for operations concerning IRB Activities, regulations, standard operation processes, and validation protocols.
Verify all activities related to human subject research are conducted in accordance with IRB determinations and approvals.
Prepare for initial ISO certification audit and establishment of Registrar. Following initial certification, maintain standards appropriately to ensure continuing certification to ISO standards.
Prepare, facilitate and participate in quarterly QA Management Meetings and quarterly Change Control Meetings.
Perform internal audits, manage results and report results to executive management.
Coordinate and Manage Supplier Qualification and Vendor Qualification processes. Maintain all applicable documentation and records.
Process Improvement activities including developing statistical reports for tracking and trending quality system reports for reporting to executive management.
Participate as a team member, or serve as project lead, and manage quality improvement projects.
Evaluate & review operational policies and procedures to ensure that SOPs are:
Clear, accurate, concise and complete
Define appropriate process
Meet all regulatory requirements
Evaluate and approve employee training and competency programs to ensure compliance with all regulatory requirements.
Communicate all quality related issues and trends to executive management and provide periodic reports on regulatory and quality assurance matters.
Responsible for developing, maintaining and training on QA, Quality Systems, and Regulatory policies and procedures. Includes Document Control and Records Management policies and procedures.
Develop a Quality Manual that:
Describes the key elements of the quality concepts observed at HemaCare Corporation
Serves as the primary quality unit resource for problematic identification, resolution, loss reporting, and continuous improvement
Support regulatory inspections and Supplier Qualification Audits, coordinate responses, maintain all applicable documentation and records.
Ensure all materials received and services performed conforms to specifications:
Maintain an approved supplier list
Establish and maintain quality agreements/contracts where applicable
Define the type and extent of controls for each type of material based on criticality (i.e., a tiered system)
Authority to approve and/or reject all components product containers, closures, in-process materials, packaging materials, labeling and final product as per regulatory requirements.
Obtain and maintain all required licenses, permits, registrations and accreditations.
Monitor all applicable government and accreditation agency regulations and requirements to ensure compliance. Notify operations of regulatory changes.
Communicate with and advise, as appropriate, customers and sales staff regarding regulatory and quality assurance requirements and activities.
Quality system reports oversight including deviations, complaint, exceptions, MRBs, etc. Monitors compliance and generates statistics for tracking and trending purposes. Assist in the development of Corrective Actions and Preventative Actions.
Develop and maintain a risk management/analysis system, according to ICH guidelines to evaluate risks based on scientific data, experience or documentation to ensure limited risk to the product and patient.
Oversight of document control activities including working with document control staff to maintain strict document control of SOPs, forms, validation plans and other associated documents.
Oversight of donor deferral activities including product quarantine/retrieval/recall, consignee notifications and Federal, State, and County notifications, and review of records: Post Donation Information, abnormal test results, potential duplicate donors.
Interface with regulatory agencies, accreditation bodies, and customers on issues related to Quality and Regulatory systems and/or IRB issues.
Expeditiously expand, build, and train the QA & RA team to meet all applicable regulatory compliance regulations and fulfill oversight responsibilities for Local, State, Federal, International (including, but not limited to, European Medicines Agency (EMA), FDA, AABB, OSHA and other applicable agencies.
Reports to Chief Executive Officer.
Work closely with HemaCare Medical Director to ensure that operational and clinical activities, policies and procedures meet standards to ensure donor, staff and patient safety.
Prepares and manages the budget for the quality assurance department.
Performs all other duties, at the discretion of management, as assigned.
Supervisory Responsibilities: The Sr. Director, Quality Assurance & Regulatory Affairs supervises QA & RA staff and is responsible for the selection of qualified candidates for any open positions in the department, conducting performance evaluations including on-site competency assessments of each staff member at least annually, ensuring training and development of staff, mentoring, coaching and counseling team members. Also responsible for documenting expectations including performance improvement plans, assigning and monitoring staff’s daily activities.
Pay Range: BOE
Posted Date: 10/30/2019
HemaCare is an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.
Discretion in handling confidential and sensitive matters.
Interpersonal skills; ability to explain instructions in an uncomplicated fashion
Excellent relationship building skills, internal & external
Excellent decision making and problem-solving skills
Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint
Ability to quickly learn new software programs as needed
Staff must wear Personal Protective Equipment (PPE) when performing tasks that may expose to blood borne pathogens, waste, infectious material, dry ice and liquid nitrogen or as required per policy.
Education, Experience and Licensure
10+ years of relevant GxP experience in Cellular Products or Blood Donor Center operations and/or Quality Assurance experience required.
5+ years supervisory or management experience required.
BA/BS degree in life sciences. Advance degree is highly preferable.
Clinical Research certification or MT (ASCP) SBB preferred.
Working knowledge of federal and state requirements for human subject research protection, peripheral stem cell collections, and blood donor centers.
Experience in IT and software validation.
Previous experience with FDA and EMA requirements related to cleanrooms and sterile manufacturing required.
Ability to work effectively with cross-functional teams.
Demonstrate excellence in all communication and interpersonal skills. Able to develop and maintain cooperative working relationships with other staff members, management, physicians, and customers.
Internal Number: 2563
About HemaCare Corporation
HemaCare is a global leader in the customization of human-derived biological products and services for biomedical research, drug discovery, process development, and cell and gene therapy starting material. HemaCare relocated its operations and corporate headquarters to a larger, state-of-the-art facility with four GMP-compliant cleanrooms in the city of Northridge. CA.